U.S. Center for Device and Radiological Health (CDRH) officials expounded on two crucial guidance documents that describe the FDA’s regulation of next-generation sequencing (NGS), as the agency aims to optimize its oversight of the technology and fulfill its role within President Obama’s Precision Medicine Initiative.
Boston Scientific Corp.'s stock spiked more than 2 percent on news that the company has reached a $275 million settlement with the Internal Revenue Service over transfer pricing issues associated with the company's $27 billion acquisition of Guidant Corp. in 2006. When finalized, the settlement will remove a potential headwind, and demonstrate Boston Scientific's continued recovery from the disastrous takeover of the cardiology implant maker.
Waltham, Mass.-based Alere Inc. is discontinuing its Inratio and Inratio 2 PT/INR blood monitoring devices after the FDA said a study of the products' software enhancements was inadequate. The company's stock fell more than 3 percent on the news, which will result in charges of between $70 million and $90 million this year.
The U.S. Federal Trade Commission requested more information about the impending $25 billion merger of St. Jude Medical Inc. and Abbott Laboratories, meaning the earliest date at which the deal can close has been extended by 30 days.
U.S. heart disease patients will have access to dissolvable, impermanent stents due to the FDA approval of Abbott Laboratories' Asborb bioresorbable stent, which will enable the high-profile device to hit the market after years of clinical trials, and fierce debate over its safety and efficacy.
